Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
FDA 510(k) K153250 · Renovis Surgical Technologies
510(k) numberK153250
Submission
- Device name
- Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
- Applicant
- Renovis Surgical Technologies
Redlands, CA, US - Received
- November 9, 2015
- Decision date
- March 16, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
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|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional | Osseus Fusions Systems, LLC | 08/21/2026SE |
| K261451 | ZSAlign Cervical Interbody SystemOVE · Traditional | ZSFab, Inc. | 07/31/2026SE |
| K262094 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 07/22/2026SE |
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | Nexus Spine | 06/22/2026SE |
| K252982 | CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional | Avalign Technologies, Inc. | 06/18/2026SE |
| K260036 | NeckTune 3D SA Cervical CageOVE · Traditional | Medyssey Co, Ltd. | 06/15/2026SE |
| K260660 | SABER-C SystemOVE · Traditional | Elevation Spine | 04/27/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/15/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
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| 510(k) | Device | Decision |
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| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemJWH · Traditional | 06/20/2019SE |
| K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemOVD · Traditional | 12/07/2018SE |
| K181655 | Renovis S180 Lateral Lumbar Interbody Fusion SystemMAX · Traditional | 09/11/2018SE |
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) SystemOVD · Traditional | 06/14/2018SE |
| K171543 | Renovis Surgical Hip Replacement SystemOQG · Traditional | 11/16/2017SE |
| K170888 | Renovis S141 Lumbar Interbody Fusion SystemMAX · Traditional | 08/08/2017SE |
| K152193 | Renovis Anterior Cervical Plate SystemKWQ · Traditional | 09/25/2015SE |
| K143647 | Renovis Surgical Hip Replacement SystemOQG · Traditional | 05/11/2015SE |
| K143126 | Renovis S141 Lumbar Interbody Cage SystemMAX · Traditional | 02/06/2015SE |
| K141676 | Renovis Surgical Porous Acetabular Cup SystemLPH · Traditional | 11/04/2014SE |
Questions and answers
When was Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System cleared by the FDA?
Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (K153250) received a 510(k) decision of Substantially Equivalent on March 16, 2016, 128 days after the submission was received.
What is the product code of K153250?
The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.